A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea

June 3, 2011 updated by: Pfizer

A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-associated Diarrhea

The purpose of this study was to determine the efficacy and safety of calcium carbonate for the prevention of nelfinavir-associated diarrhea and to evaluate the efficacy and safety of calcium carbonate in combination with loperamide for the treatment of nelfinavir-associated diarrhea.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
    • Florida
      • Ft. Lauderdale, Florida, United States, 33308
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10011
        • Pfizer Investigational Site
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77098
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Antiretroviral-naive patients with HIV-1 infection
  • not more than 2 loose stools per day or any preexisting or emerging medical condition that would interfere with the evaluation of therapeutic response of the study drug
  • No antidiarrheal medication within 7 days prior to entry

Exclusion Criteria:

  • Greater than or equal to 2 loose stools per day lasting 2 or more days within 7 days prior to study entry
  • Bloody stools within 7 days prior to study entry
  • Any unstable or severe intercurrent medical condition, including active opportunistic infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Calcium Carbonate
Calcium carbonate 500 mg oral tablet twice a day; given in combination with the following antiretroviral combination: nelfinavir 1250 mg twice a day, and lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day); If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly; All study drugs continued through to Week 12
Drug: nelfinavir
1250 mg twice a day
Other Names:
  • Viracept
Drug: lamivudine
lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
Drug: loperamide
If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly;
Drug: nelfinavir
nelfinavir 1250 mg twice a day
Other Names:
  • Viracept
Experimental: 2
Drug: nelfinavir
1250 mg twice a day
Other Names:
  • Viracept
Drug: nelfinavir
nelfinavir 1250 mg twice a day
Other Names:
  • Viracept
Other: Calcium carbonate not administered
Prophylaxis with calcium carbonate not administered in this group; The following antiretroviral combination was administered: nelfinavir 1250 mg twice a day, and lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
Drug: lamivudine + zidovudine
lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients who experienced protocol-defined diarrhea in each treatment group during study
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first occurrence of protocol-defined diarrhea
The outcome of calcium carbonate plus loperamide in treating subjects who experienced diarrhea
Time Frame: Weeks 2, 4, 6, 8, and 12
Weeks 2, 4, 6, 8, and 12
Frequency and severity of diarrhea collected from the subject daily diary during the study will be summarized before and after subjects receive calcium carbonate plus loperamide
Time Frame: Weeks 2, 4, 6, 8, and 12
Weeks 2, 4, 6, 8, and 12
Safety evaluations including physical exam, weight and vital signs measurements
Time Frame: Screening, baseline, Weeks 2, 4, 6, 8, and 12
Screening, baseline, Weeks 2, 4, 6, 8, and 12
Safety assessment of laboratory parameters
Time Frame: Screening, baseline, Weeks 4, 8, and 12
Screening, baseline, Weeks 4, 8, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 2, 2008

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 3, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4301004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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